Who is the manufacturer of TRUZONE PEAK FLOW METER?

Monaghan Medical Corp. filed the 510(k) submission for TRUZONE PEAK FLOW METER (K963089).

What is the FDA product code for TRUZONE PEAK FLOW METER?

BZH. It is classified under 21 CFR 868.1860 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for TRUZONE PEAK FLOW METER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TRUZONE PEAK FLOW METER?

TruZone Peak Flow Meter (K926307); TruZone Peak Flow Meter (K955262).

Who can help prepare an FDA 510(k) submission like TRUZONE PEAK FLOW METER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TRUZONE PEAK FLOW METER

K963089 · Monaghan Medical Corp. · BZH · Nov 6, 1996 · Anesthesiology

Device Facts

Record ID	K963089
Device Name	TRUZONE PEAK FLOW METER
Applicant	Monaghan Medical Corp.
Product Code	BZH · Anesthesiology
Decision Date	Nov 6, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1860
Device Class	Class 2

Intended Use

The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver.

Device Story

Mechanical device; measures Peak Expiratory Flow Rate (PEFR). User places inlet in mouth; performs forced exhalation from full lungs. Internal piston extends spring via pressure spike; pushes indicator to maximum displacement position. Indicator remains at peak value; user reads PEFR in liters per minute from logarithmic scale. Used by patients for self-monitoring; provides objective data for respiratory assessment.

Clinical Evidence

Bench testing only; device performance verified against November 1994 ATS Standards.

Technological Characteristics

Mechanical peak flow meter; logarithmic scale for increased resolution at low flow rates. Piston-spring mechanism. No electronic components or software.

Indications for Use

Indicated for patients requiring measurement of Peak Expiratory Flow Rate (PEFR) via forced exhalation maneuver to monitor respiratory function.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

TruZone Peak Flow Meter (K926307)
TruZone Peak Flow Meter (K955262)

Related Devices

K955234 — TRUPEAK PEAK FLOW METER · Monaghan Medical Corp. · Mar 18, 1996
K963095 — TRUPEAK PEAK FLOW METER · Monaghan Medical Corp. · Nov 4, 1996
K955262 — TRUZONE PEAK FLOW METER · Monaghan Medical Corp. · Mar 7, 1996
K082899 — DYNAMIPEAK PEAK FLOW METER · Dynamitech Medical, Inc. · Mar 10, 2009
K172804 — Besmed Peak Flow Meter · Besmed Health Business Corp · Jan 11, 2018

Submission Summary (Full Text)

{0} K963089 NOV - 6 1996 # SECTION 2 - SUMMARY AND CERTIFICATION ## 510(k) SUMMARY Monaghan Medical Corporation 5 Latour Ave., Suite 1600 P.O. Box 2805 Plattsburgh, NY 12901-0299 Phone: 518-561-7330 Fax: 518-561-5660 Contact: James A. Cochie QA/RA Manager **Date Prepared:** July 11, 1996 **Device Proprietary Name:** TruZone Peak Flow Meter **Device Classification name:** Peak Flow Meter for Spirometry, 73 BZH **Legally Marketed Device Identity:** TruZone Peak Flow Meter, 510(k) #926307, #955262 ## Device Description: The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings. The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update.